Defal 6 mg comprimidos efg

PATIENT INFORMATION LEAFLET

Defal 6 mg tablets EFG

Read this leaflet carefully before you start taking the medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If you think you have suffered a side effect, you can help us by reporting it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

1.What isDefal6 mg tablets and what it is used for

2.Before takingDefal6 mg tablets

3.How to takeDefal6 mg tablets

4.Possible side effects

5.Storage ofDefal6 mg tablets

6.Further information

Defal6 mg tablets is a medication belonging to a group of medications known as corticosteroids, which have anti-inflammatory and antiallergic properties.

Defal6 mg tablets is indicated for the treatment of:

• Rheumatic and collagen diseases: such as rheumatoid arthritis, psoriatic arthritis, and systemic lupus erythematosus.
• Skin diseases: such as pemphigus, generalized exfoliative dermatitis, and severe psoriasis.
• Allergic diseases: bronchial asthma that does not respond to conventional treatment.
• Pulmonary diseases: sarcoidosis, organic dust pneumoconiosis, idiopathic pulmonary fibrosis.
• Eye diseases: choroiditis, chororetinitis, iritis, and iridocyclitis.
• Blood diseases: idiopathic thrombocytopenia, hemolytic anemias, and palliative treatment of leukemias and lymphomas.
• Gastrointestinal and liver diseases: ulcerative colitis, Crohn's disease, and active chronic hepatitis.
• Kidney diseases: nephrotic syndrome.

Do not takeDefal6 mg tablets:

• If you are allergic (hypersensitive) to deflazacort or to any of the other components of this medication.

• If you have a stomach ulcer.
• If you suffer from bacterial infections (active tuberculosis) and viral infections (herpes simplex eye, herpes zoster, varicella) or generalized infections caused by fungi.
• If you are in the pre- or post-vaccination period.

Be especially careful withDefal6 mg tablets:

• It is essential that your doctor knows all the diseases you have or have had before they can advise you on this treatment. You must especially inform them of cardiovascular diseases (heart failure, high blood pressure), those caused by blood clots (thrombosis, embolism), digestive or intestinal diseases (stomach ulcer, intestinal inflammation, chronic diarrhea), important liver or kidney diseases, diabetes, osteoporosis, behavioral disorders (mood changes, insomnia), epilepsy, glaucoma, thyroid gland insufficiency, muscle weakness, and certain acute or chronic infections.

• Do not get vaccinated during treatment with this medication. Your doctor will indicate what you should do in these cases. Inform them also if you have recently been to tropical countries.

• In prolonged treatments, eye alterations may appear, so your doctor may advise you to visit an ophthalmologist periodically.

• Consult your doctor if you experience blurred vision or other visual alterations.

• You must increase the dose of corticosteroids in special situations (surgery, infections, and others) and therefore your doctor must know if you have had any other disease.

• In children, the prolonged use of this medication may stop their growth and development.

• After a long treatment withDefal6 mg tablets, it should be gradually discontinued. Do not stop this medication without consulting your doctor first.

Use in athletes

You should warn patients that this medication contains deflazacort, which may produce a positive result in doping control tests.

Use of other medications

Inform your doctor or pharmacist if you are using, or have recently used, other medications, even those purchased without a prescription.

• Some medications may increase the effects ofDefal6 mg tablets, so your doctor will make thorough checks if you are taking these medications (including some for HIV: ritonavir, cobicistat).

In particular, inform your doctor or pharmacist if you are taking any of the following medications, asDefal6 mg tablets may interact with them:

• Pain or anti-inflammatory medications.
• Diabetes medications.
• Diuretics.
• Antibiotics.
• Estradiol or oral contraceptives.
• Medications that cause muscle relaxation.
• Anticholinesterase medications, used in myasthenia gravis.
• Medications for heart failure or coagulation disorders.
• Vaccines and toxoids.
• Medications for epilepsy and those used in psychiatric treatments (phenytoin, phenobarbital).

Do not take any of these medications at the same time asDefal6 mg tablets without your doctor's knowledge.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Human experience is limited, soDefal6 mg tablets should only be used in cases where the risk-benefit assessment previously advises its use.

Defal6 mg tablets are excreted in breast milk, so it is not recommended to use it during breastfeeding.

Driving and operating machinery

No data are available, although it is advisable that, until the treatment response is satisfactory, you do not perform tasks that require special attention, such as driving vehicles, operating hazardous machinery, etc.

Important information about one of the components ofDefal6 mg tablets

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions for Defal 6 mg tablets as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

This medication is administered orally. The tablets should be swallowed without chewing, with a little liquid.

The dose must be individualized. Therefore, the number and frequency of tablets that you should take will be determined by your doctor based on the type and severity of your disease, as well as your response to treatment.

In adults, the dose may range from 6 to 90 mg per day, and in children from 0.25 to 1.15 mg/kg. It is essential that you understand perfectly the instructions provided by your doctor regarding the administration of the medication, and in case of doubt, do not hesitate to consult them.

Your doctor will inform you of the duration of treatment. Do not stop taking it before, nor without authorization, and never discontinue it abruptly.

In special situations (stress, major infections, severe trauma, or surgical interventions), it may be necessary to adjust the dose. Consult with your doctor to explain the course of action to follow in these cases.

After prolonged treatment, the administration of this medication should never be stopped abruptly. Your doctor will inform you how to gradually reduce the dose. It is also essential that you maintain contact with your doctor at the end of treatment to act in case of reappearance of symptoms.

If you take more Defal 6 mg tablets than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Defal 6 mg tablets

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Defal 6 mg tablets

Prolonged treatments that are stopped abruptly may cause: fever, discomfort, and muscle and joint pain.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medications,Defal6 mg tablets may have adverse effects, although not everyone will experience them.

In short-term treatments, this medication is well tolerated and adverse effects are rare. However, in prolonged treatments, the following have been observed:

• Gastrointestinal disorders:Stomach ulcers, hemorrhage, heavy digestion, acute pancreatitis-inflammation of the pancreas-(especially in children).
• Neurological disorders:Headache, dizziness, agitation, insomnia, mood changes (depression, euphoria) and increased intracranial pressure.
• Skin disorders:Thin skin, stretch marks, and acne.
• Cardiovascular and vascular disorders:Increased blood pressure, fluid retention in tissues (edema), heart failure, complications caused by blood clots (thromboembolism), decreased potassium, and salt retention.
• Endocrine disorders:Adrenal insufficiency (failure of the adrenal gland), weight gain, and moon face, worsening of diabetes, cessation of menstruation, and delayed growth in children.
• Musculoskeletal and connective tissue disorders:Muscle weakness or alterations, osteoporosis.
• Eye disorders:Eye changes (cataracts, increased intraocular pressure).

With an unknown frequency (frequency cannot be estimated from available data): blurred vision.

During treatment with this medication, your tendency to infections may increase, so if you notice any symptoms of illness that may be related to taking this medication, contact your doctor.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es/. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

No special storage conditions are required.

Keep out of the reach and sight of children.

Do not useDefal6 mg tablets after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition ofDefal6 mg tablets

The active ingredient is deflazacort.

The other components are: lactose monohydrate, cornstarch, microcrystalline cellulose and magnesium stearate.

Appearance of the product and content of the container:

Round, non-coated tablets, white, with a cross engraved on one face and the number 6 on the other.

The tablet can be divided into equal parts.

Defal6 mg tablets are packaged in PVC blisters and aluminum-PVC laminates and are presented in containers containing 20 or 500 tablets.

Other presentations

Defalis also marketed in 30 mg tablets.

Marketing authorization holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Responsible for manufacturing

Faes Farma, S.A.

Maximo Agirre Kalea, 14

48940 Leioa (Bizkaia)

Spain

O

Faes Farma, S.A.

Parque Científico y Tecnológico de Bizkaia

Ibaizabal Bidea, Edificio 901

48160 Derio (Bizkaia)

Spain

Last review date of this leaflet:January 2025

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es./